SenzaGen is focusing on the chemical, cosmetics, pharmaceutical and medical device markets for global commercialization of the in vitro platform GARD®.

In 2017 and 2018, SenzaGen has gradually strengthened its commercial organisation and global presence through new agreements with strategic partners. The background to the recruitment in the US is that SenzaGen intends to accelerate its collaborations with both US licensees and industrial partners for the development of the GARD®portfolio.

“The US is a priority market, and through the recruitment of Joshua J. Schmidt, we are strengthening our organisation by adding significant network, knowledge and insight into the US market, which contributes to achieving our financial targets,” says Anki Malmborg Hager, CEO of SenzaGen

Joshua J. Schmidt has extensive business and scientific experience from 3M, Medtronic and Bruker Daltonics, most recently as Senior Account Executive for a US-based CRO, Pace Analytical Life Sciences, where he worked with testing of pharmaceutical products and medical devices in the US.

“SenzaGen’s technology is impressive and has true potential to significantly and positively impact the chemical and life science industries. I am excited to join SenzaGen at this time because I see great opportunity and potential for growth in the US and globally for GARD®”, says Joshua J. Schmidt, Business Development Director at SenzaGen Inc.

In conjunction with Joshua J. Schmidt’s appointment as Business Development Director, SenzaGen Inc becomes a wholly-owned subsidiary of SenzaGen AB (publ).

GARD® is a group of tests for assessing chemical skin sensitizers. The tests make use of genetic biomarkers for more than 200 genes which cover the entire immune reaction and are relevant to predicting the risk of hypersensitivity. The tests have over 90 percent reliability.

This compares with the current predominant test method, experiments on mice, which has an accuracy of 70-75 percent. SenzaGen’s tests are also capable of measuring the potency of a substance’s allergenic properties. Consequently, GARD tests provide a much more comprehensive basis for determining whether a substance should be classified as an allergen than current testing methods.

About SenzaGen

SenzaGen makes it possible to replace animal experiments with in vitro genetic testing to determine the allergenicity of the chemicals we come into contact with in our daily lives, such as for example in cosmetics, pharmaceuticals, food products and dyes. The company’s patented tests are the most reliable on the market and provide more information than traditional evaluation methods. We ourselves sell the tests in Sweden and the USA, and we sell through partners in several other countries. Over the next few years the company will expand geographically, make alliances with more distribution partners and launch further unique tests. SenzaGen has its headquarters in Lund in Sweden and a subsidiary in Delaware USA. For more information visit http://www.senzagen.com

This information is information that SenzaGen is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the contact person set out aboveon October 11, 2018, at 08.30.

SenzaGen AB is listed on Nasdaq First North in Stockholm and FNCA is the company’s Certified Adviser. For more information, please visit http://www.senzagen.com

https://senzagen.com/wp-content/uploads/2018/08/a100bfb83b671332_org.jpg13662396https://senzagen.com/wp-content/uploads/2017/01/LoggaSquare_RGB_liten_HF.png2018-10-11 06:30:002018-10-11 06:30:00Senzagen strengthens US organisation and commercial presence with aim to enroll more licensees

SenzaGen focuses on the chemical, cosmetics, pharmaceutical and medical device markets for the global commercialization of the in vitro platform GARD®. In 2017 and 2018, SenzaGen has gradually strengthened its commercial organization and global presence with new agreements with strategic partners. The efforts are now accelerating with both more CRO partnerships and more collaborations with industrial partners for the company’s broad product pipeline. In the autumn, SenzaGen announced that the company will also target its sales efforts towards the growing medical device market. In addition, SenzaGen has recently launched another test based on its platform, GARDair, the first in vitro test for airway allergies.

The new financial goals being adopted are:

To achieve a turnover of MSEK 300 in 2023 with sustainable sales growth exceeding 30% and a sustainable gross margin exceeding 50% for the years to follow.

To reach break-even in 2021 with a turnover of 80 MSEK.

“There are a number of factors that indicate strong and sustainable future sales growth. The interest and demand for animal-free tests is strong and keeps growing as new regulations reduce the possibility of using technically and ethically substandard animal tests. We will sustain our pace of product development to meet the biggest and most urgent challenges that the different industries face. We are in the forefront of the field and we are now broadening our strategy by putting a strong focus on recruiting strong CRO and industrial partners in all our market segments and geographies,” says Anki Malmborg Hager, CEO of SenzaGen.

SenzaGen’s financial targets set forth above constitute forward-looking information and are based on a number of assumptions about the operating environment in which the Company operates. This may vary significantly and be inferior to SenzaGen’s assessments when the financial targets were adopted. As a consequence, SenzaGen’s ability to achieve the financial targets will depend on uncertainties and contingencies, some of which are outside the Company’s control. There is no guarantee that SenzaGen can achieve the targets or that the Company’s financial position or operating profit will not differ significantly from the financial targets.

GARD® is a group of tests for assessing chemical skin sensitizers. The tests make use of genetic biomarkers for more than 200 genes which cover the entire immune reaction and are relevant to predicting the risk of hypersensitivity. The tests have over 90 percent reliability.

This compares with the current predominant test method, experiments on mice, which has an accuracy of 70-75 percent. SenzaGen’s tests are also capable of measuring the potency of a substance’s allergenic properties. Consequently, GARD tests provide a much more comprehensive basis for determining whether a substance should be classified as an allergen than current testing methods.

About SenzaGen

SenzaGen makes it possible to replace animal experiments with in vitro genetic testing to determine the allergenicity of the chemicals we come into contact with in our daily lives, for example in cosmetics, pharmaceuticals, food products and dyes. The company’s patented tests are the most reliable on the market and provide more information than traditional evaluation methods. We ourselves sell the tests in Sweden and the USA, and we sell through partners in several other countries. Over the next few years the company will expand geographically, make alliances with more distribution partners and launch further unique tests. SenzaGen has its headquarters in Lund in Sweden and a subsidiary in San Francisco, USA. For more information visit http://www.senzagen.com

This information is information that SenzaGen is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the contact person set out aboveon October 9, 2018, at 08.30.

SenzaGen AB is listed on Nasdaq First North in Stockholm and FNCA is the company’s Certified Adviser. For more information, please visit http://www.senzagen.com

Respiratory allergies or respiratory sensitization, which manifests itself primarily in the form of asthma, is a growing problem. About 8-10% of the Swedish population suffer from asthma and more than 300 million people worldwide are diagnosed with asthma – a figure that is expected to increase in the next few years. There are currently no methods available for testing if chemicals can contribute to or cause allergic reactions in the respiratory tract. GARDair makes use of genetic biomarkers which cover the entire immune reaction and are relevant to predicting the risk of hypersensitivity with high accuracy. GARDair is targeted primarily at the chemical, pharmaceutical and cosmetic industries where there are a wide range of testing needs from pesticides to fragrances. GARDair will be marketed through SenzaGen’s laboratory in Lund and the company’s licensing laboratories, which will allow immediate availability in Europe and the United States.

Using the same technology platform as the already launched GARDskin, GARDair is supported by the EU’s SME program Horizon2020 and has been developed in cooperation with AstraZeneca.

“I have been advising SenzaGen in their preparations for the commercialization of GARDair in my capacity as external and independent Horizon2020 coach. SenzaGen is for me a true EU success story and meets the aims of Horizon2020 by translating an excellent technology platform into a number of excellent products and offerings for the market. It is a true ’High-Tech’ business. They have unique products in growth markets and excellent management. I believe that GARDair will contribute to making SenzaGen a very profitable and successful company,” says Paul Yianni, Horizon2020 coach.

“There is a huge demand for GARDair from customers in the chemicals, pharmaceutical and cosmetics industries. The ability to test without using animal models whether substances might cause airway allergies brings major benefits in several ways – not only when it comes to developing better and safer products, but also by offering employees a safe production and working environment. GARDair in combination with GARDskin provides new insights and thereby new opportunities for our customers to actively avoid chemicals with multiple allergenic effects,” says Anki Malmborg Hager, CEO of SenzaGen.

SenzaGen will unveil GARDair at the 20th International Congress on In Vitro Toxicology (ESTIV2018), October 15-18, 2018 in Berlin, Germany.

About GARD®GARD® is a group of tests for assessing chemical skin sensitizers. The tests make use of genetic biomarkers for more than 200 genes which cover the entire immune reaction and are relevant to predicting the risk of hypersensitivity. The tests have over 90 percent reliability. This compares with the current predominant test method, experiments on mice, which has an accuracy of 70-75 percent. SenzaGen’s tests are also capable of measuring the potency of a substance’s allergenic properties. Consequently, GARD tests provide a much more comprehensive basis for determining whether a substance should be classified as an allergen than current testing methods.

About SenzaGenSenzaGen makes it possible to replace animal experiments with in vitro genetic testing to determine the allergenicity of the chemicals we come into contact with in our daily lives, such as for example in cosmetics, pharmaceuticals, food products and dyes. The company’s patented tests are the most reliable on the market and provide more information than traditional evaluation methods. We ourselves sell the tests in Sweden and the USA, and we sell through partners in several other countries. Over the next few years the company will expand geographically, make alliances with more distribution partners and launch further unique tests. SenzaGen has its headquarters in Lund in Sweden and a subsidiary in San Francisco, USA. For more information visit http://www.senzagen.com

This information is information that SenzaGen is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the contact person set out aboveon September 18, 2018, at 17:30.

SenzaGen AB is listed on Nasdaq First North in Stockholm and FNCA is the company’s Certified Adviser. For more information, please visit http://www.senzagen.com

SenzaGen originally submitted the final validation report for GARDskin to the regulatory authorities in 2018, thereby fully complying with ECVAM and OECD deadlines. The report shows that GARDskin can determine with 93.8% accuracy if chemical substances pose a risk of causing allergies. This result confirms the superiority of GARDskin over all currently available validated methods. It is also the first test to include the long required potency classification in vitro, which is a requirement for registration of chemicals and also requested by customers. GARDskin is unique in that it provides a holistic view by including analysis of multiple human immunological responses in a single test. In addition, GARDskin is the first test to be validated in which biology, genomics and high-tech algorithms are combined, leading to high safety levels.

ECVAM (European Centre for the Validation of Alternative Methods) has announced that because of a high workload the evaluation of GARDskin is now scheduled for an extra meeting to be held in the spring of 2019. This in turn means that a decision by the OECD regarding the validation of GARDskin is now expected in 2020.

“SenzaGen has had a broad marketing strategy from our start and we are constantly working to expand it further. This has involved focusing the company’s resources on large markets and applications where demand for regulatory approval is limited and thus our total future revenues are only partially dependent on an OECD validation,” says SenzaGen CEO Anki Malmborg Hager.

A telephone conference is scheduled on September 19, 2018, 8:00 am CET to answer questions and further elaborate on this news. The conference will be held in Swedish.

Participant dial in numbers:

SE: +46856642662
UK: +442033645373

On the SenzaGen website, under Investors/Pressmeddelanden (http://senzagen.com/investors/pressmeddelanden/) there will be an MP3 file for those who want to listen to the conference call later, the file is available within two hours of the end of the conference call.

About GARD®GARD® is a group of tests for assessing chemical skin sensitizers. The tests make use of genetic biomarkers for more than 200 genes which cover the entire immune reaction and are relevant to predicting the risk of hypersensitivity. The tests have over 90 percent reliability. This compares with the current predominant test method, experiments on mice, which has an accuracy of 70-75 percent. SenzaGen’s tests are also capable of measuring the potency of a substance’s allergenic properties. Consequently, GARD tests provide a much more comprehensive basis for determining whether a substance should be classified as an allergen than current testing methods.

About SenzaGenSenzaGen makes it possible to replace animal experiments with in vitro genetic testing to determine the allergenicity of the chemicals we come into contact with in our daily lives, such as for example in cosmetics, pharmaceuticals, food products and dyes. The company’s patented tests are the most reliable on the market and provide more information than traditional evaluation methods. We ourselves sell the tests in Sweden and the USA, and we sell through partners in several other countries. Over the next few years the company will expand geographically, make alliances with more distribution partners and launch further unique tests. SenzaGen has its headquarters in Lund in Sweden and a subsidiary in San Francisco, USA. For more information visit http://www.senzagen.com

This information is information that SenzaGen is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the contact person set out aboveon September 18, 2018, at 17.30.

SenzaGen AB is listed on Nasdaq First North in Stockholm and FNCA is the company’s Certified Adviser. For more information, please visit http://www.senzagen.com

Today, SenzaGen focuses on the chemicals, cosmetics and pharmaceutical markets for its global commercialization of GARD®, an in vitro platform for risk assessment of chemicals. Now, the Company has decided to further expand its market presence and will also focus its efforts on the global market for medical devices.

“We see significant opportunities in the medical device market. Large underlying growth combined with a willingness to use in vitro tests to assess the risk profile of medical devices and a new regulatory framework means that the medical device market will be a natural next step for SenzaGen,” says Anki Malmborg Hager, CEO of Senzagen.

The global medical technology market is estimated to be worth $410 billion in 2023 with an annual increase of 4.5% in 2018-2023. All medical devices that come into contact with the patient must be assessed for allergy before they can be sold. The market potential of testing and risk assessment of medical devices is therefore very large and increasing. At the moment, changes are made in the EU regulatory framework for medical devices while the global ISO Standard ISO 10993 for the approval of medical devices is updated. So far, ISO 10993 has required tests on guinea pigs for sensitization, but work is ongoing to update the standard to include animal-free tests, which SenzaGen can capitalize on.

In order to increase the introduction pace, the Company has signed a cooperation agreement with Research Institutes of Sweden (RISE) in order to adapt GARD® for testing medical devices. Furthermore, Eurofins, licensee to GARD®, is a major player in the medical devices market and will therefore be able to expand its offer to this market.

A first step in the adaptation of GARD® for medical devices will be presented as a poster at the EUROTOX conference in Brussels, 2-5 September 2018.

About GARD®GARD® is a group of tests for assessing chemical skin sensitizers. The tests make use of genetic biomarkers for more than 200 genes which cover the entire immune reaction and are relevant to predicting the risk of hypersensitivity. The tests have over 90 percent reliability. This compares with the current predominant test method, experiments on mice, which has an accuracy of 70-75 percent. SenzaGen’s tests are also capable of measuring the potency of a substance’s allergenic properties. Consequently, GARD® tests provide a much more comprehensive basis for determining whether a substance should be classified as an allergen than current testing methods.

About SenzaGenSenzaGen makes it possible to replace animal experiments with in vitro genetic testing to determine the allergenicity of the chemicals we come into contact with in our daily lives, such as for example in cosmetics, pharmaceuticals, food products and dyes. The company’s patented tests are the most reliable on the market and provide more information than traditional evaluation methods. We ourselves sell the tests in Sweden and the USA, and we sell through partners in several other countries. Over the next few years the company will expand geographically, make alliances with more distribution partners and launch further unique tests. SenzaGen has its headquarters in Lund in Sweden and a subsidiary in San Francisco, USA. For more information visit http://www.senzagen.com

The information was submitted for publication, through the contact person set out above on the August 29, 2018 at 08.45.

SenzaGen AB are listed on Nasdaq First North in Stockholm and FNCA is the company’s Certified Adviser. For more information, please visit http://www.senzagen.com

Shareholders who wish to attend the extraordinary general meeting must be included in the share register maintained by Euroclear Sweden AB on the record date, which is Saturday 1 September 2018, (since the record day occurs on a Saturday a shareholder must be registered in the share register maintained by Euroclear Sweden AB no later than on 31 August 2018).

Shareholders shall also to notify the Company of their participation and any assistants (no more than two) in the extraordinary general meeting no later than Monday 3 September 2018. The notification shall be in writing to SenzaGen, Medicon Village, building 401, 223 81 Lund or via e-mail: anmalan@senzagen.com. The notification should state the name, personal/corporate identity number, shareholding, address and telephone number and, when applicable, information about representatives, counsels and assistants. When applicable, complete authorization documents, such as registration certificates and powers of attorney for representatives and assistants, should be appended the notification.

Nominee shares

Shareholders, whose shares are registered in the name of a bank or other nominee, must temporarily register their shares in their own name with Euroclear Sweden AB in order to be entitled to participate in the general meeting. Such registration, which normally is processed in a few days, must be completed no later than 31 August 2018 and must therefore be requested from the nominee well before this date.

Proxy etc.

Shareholders represented by proxy shall issue dated and signed power of attorney for the proxy. If the proxy is issued by a legal entity, attested copies of the certificate of registration or equivalent authorization documents, evidencing the authority to issue the proxy, shall be enclosed. The proxy’s validity may not be more than five years from the issuance. A copy of the proxy in original and, where applicable, the registration certificate, should be submitted to the Company by mail at the address set forth above well in advance of the extraordinary general meeting. The proxy in original and, when applicable, the certificate of registration must be presented at the extraordinary general meeting. A form proxy will be available for downloading on the Company’s website http://www.senzagen.com.

Proposed agenda

Election of chairman of the meeting.

Preparation and approval of voting list.

Election of one or two persons to certify the minutes.

Question whether the general meeting has been duly convened.

Approval of the agenda.

Election of new director of the board.

Closing of the meeting.

Proposed resolutions

Item 1: Election of chairman of the meeting

The board of directors proposes that Carl Borrebaeck is elected as chairman of the general meeting.

Item 6.: Election of new director of the board

It is proposed that the board of directors shall comprise of five directors.

It is further proposed that the remuneration to the director proposed for election shall be SEK 100,000. The total remuneration for the board of directors will amount to SEK 600,000 in accordance with the remuneration resolved on by the annual general meeting.

It is proposed to elect Peter Nählstedt as new director. The directors Carl Borrebaeck (chairman), Ann Gidner, Ian Kimber and Laura Chirica remain as directors.

Further information regarding the proposed director

Peter Nählstedt

Education and background

Peter Nählstedt holds a M.Sc. in engineering and a Bachelor’s degree in Business administration. Peter was previously CEO of Probi AB and chairman of the board of International Probiotics Association Europe. He has also held several positions within GE Healthcare Life Sciences, such as general manager of BioProcess North America, and as director of South America Trelleborg Marine Systems.

Current Assignments: None

Year of birth: 1974

Nationality: Swedish

Direct or related person ownership in the Company: 0

Number of shares and votes

The total number of shares in the Company as of the date hereof amounts to 15,559,250 shares, with a corresponding number of votes. The Company holds no own shares.

Documents

The complete proposals are included in this notice. The notice and proxy forms are available at the Company at Medicon Village, building 401 in Lund and at the Company’s website http://www.senzagen.com, at least two (2) weeks in advance of the extraordinary general meeting. All documents will be sent to shareholders who request it and provide their e-mail or postal address.

The shareholders hereby notified regarding the right to, at the extraordinary general meeting, request information from the board of directors and managing director according to Ch. 7 § 32 of the Swedish Companies Act.

GARD™ is a group of tests for assessing chemical skin sensitizers. The tests make use of genetic biomarkers for more than 200 genes which cover the entire immune reaction and are relevant to predicting the risk of hypersensitivity. The tests have over 90 percent reliability.

This compares with the current predominant test method, experiments on mice, which has an accuracy of 70-75 percent. SenzaGen’s tests are also capable of measuring the potency of a substance’s allergenic properties. Consequently, GARD tests provide a much more comprehensive basis for determining whether a substance should be classified as an allergen than current testing methods.

About SenzaGen

SenzaGen makes it possible to replace animal experiments with in vitro genetic testing to determine the allergenicity of the chemicals we come into contact with in our daily lives, such as for example in cosmetics, pharmaceuticals, food products and dyes. The company’s patented tests are the most reliable on the market and provide more information than traditional evaluation methods. We ourselves sell the tests in Sweden and the USA, and we sell through partners in several other countries. Over the next few years the company will expand geographically, make alliances with more distribution partners and launch further unique tests. SenzaGen has its headquarters in Lund in

This information is information that SenzaGen is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the contact person set out aboveat August 22, 2018, at 09.30.

SenzaGen AB are listed on Nasdaq First North in Stockholm and FNCA is the company’s Certified Adviser. For more information, please visit http://www.senzagen.com

There are more and more countries banning animal testing of ingredients and final products within the cosmetics industry. Also other industries are facing a growing demand for accurate animal-free test methods. The primary forces driving this development are stricter regulatory demands and an urge to reduce the use of animals in experimental testing.

A new scientific study confirms that SenzaGen´s test method GARDskin™ is more accurate than the other animal free methods (DPRA, KeratinoSens (ARE-Nrf2 luciferase) and h-CLAT) on the market today, for skin sensitization testing. Due to the relatively low accuracy of these methods, regulatory authorities recommend a combination of them, in order to better predict the skin sensitization activity of a substance. However, not even a combination of these tests show the same high level of accuracy as displayed by GARDskin™.

”This recently published scientific study shows that GARDskin™ can give producers and contract laboratories a possibility to use one single test to evaluate their substances with even better accuracy than a combination of several test methods. GARDskin™ has the potential to make testing of chemicals more efficient with respect to time, resources and quality”, says SenzaGen CEO Anki Malmborg Hager.

The scientific study was carried out by Dr David W Roberts at the School of Pharmacy and Biomolecular Sciences, Liverpool John Moores University in the UK. The results are published in the scientific journal Regulatory Toxicology and Pharmacology and can be accessed via this link : “Is a combination of assays really needed for non-animal prediction of skin sensitization potential? Performance of the GARD™ (Genomic Allergen Rapid Detection) assay in comparison with OECD guideline assays alone and in combination”

About GARD™GARD™ is a group of tests for assessing chemical skin sensitizers. The tests make use of genetic biomarkers for more than 200 genes which cover the entire immune reaction and are relevant to predicting the risk of hypersensitivity. The tests have over 90 percent reliability. This compares with the current predominant test method, experiments on mice, which has an accuracy of 70-75 percent. SenzaGen’s tests are also capable of measuring the potency of a substance’s allergenic properties. Consequently, GARD tests provide a much more comprehensive basis for determining whether a substance should be classified as an allergen than current testing methods.

About SenzaGenSenzaGen makes it possible to replace animal experiments with in vitro genetic testing to determine the allergenicity of the chemicals we come into contact with in our daily lives, such as for example in cosmetics, pharmaceuticals, food products and dyes. The company’s patented tests are the most reliable on the market and provide more information than traditional evaluation methods. We ourselves sell the tests in Sweden and the USA, and we sell through partners in several other countries. Over the next few years the company will expand geographically, make alliances with more distribution partners and launch further unique tests. SenzaGen has its headquarters in Lund in Sweden and a subsidiary in San Francisco, USA. For more information visit http://www.senzagen.com.

The information was submitted for publication, through the contact person set out above on the 31 July 2018 at 08.50.

SenzaGen AB is listed on Nasdaq First North in Stockholm and FNCA is the company’s Certified Adviser. For more information, please visit http://www.senzagen.com.

https://senzagen.com/wp-content/uploads/2018/07/Tox_cover.gif150113admin_senzagenhttps://senzagen.com/wp-content/uploads/2017/01/LoggaSquare_RGB_liten_HF.pngadmin_senzagen2018-07-31 06:50:002018-07-31 08:59:40Scientific study shows that GARDskin™ is the most accurate test for skin sensitization of chemical substances

Eurosafe is a highly specialised contract research organization (CRO) with expertise in toxicology and regulatory services, and strives to present the best performing tests to its customers. Eurosafe carries out in vitro tests with focus on the cosmetics and pharmaceutical industries. According to the agreement, Eurosafe will market GARD™ animal free tests for skin sensitization to its large client base.

GARD™ is a platform of animal free tests developed by SenzaGen for safety assessment of chemical ingredients and mixtures. The platform offers skin sensitization testing with an accuracy of 94% and the unique possibility to add potency classification according to regulatory requirements. At the same time, GARD™ eliminates the need for laboratory animals, as the tests are performed in test tubes (in vitro).

“This agreement is important for us, as it opens up a very large market being the French cosmetics and pharmaceutical industry. We are very pleased to join efforts with a highly competent and renowned partner such as Eurosafe. Together, we have a clear vision of how GARD™ can contribute to the testing market”, says Anki Malmborg Hager, CEO of SenzaGen.

“The demand from our customers in the cosmetic and pharmaceutical industry for high performing animal free tests is continuously increasing and we strive to offer the best and latest technologies. The GARD™ assay portfolio is unique with its holistic approach and contributes greatly in a modern testing strategy”, says Ashwani Sharma, General Manager of Eurosafe.

About GARD™GARD™ is a group of tests for assessing chemical skin sensitizers. The tests make use of genetic biomarkers for more than 200 genes which cover the entire immune reaction and are relevant to predicting the risk of hypersensitivity. The tests have over 90 percent reliability. This compares with the current predominant test method, experiments on mice, which has an accuracy of 70-75 percent. SenzaGen’s tests are also capable of measuring the potency of a substance’s allergenic properties. Consequently, GARD tests provide a much more comprehensive basis for determining whether a substance should be classified as an allergen than current testing methods.

About SenzaGenSenzaGen makes it possible to replace animal experiments with in vitro genetic testing to determine the allergenicity of the chemicals we come into contact with in our daily lives, such as for example in cosmetics, pharmaceuticals, food products and dyes. The company’s patented tests are the most reliable on the market and provide more information than traditional evaluation methods. We ourselves sell the tests in Sweden and the USA, and we sell through partners in several other countries. Over the next few years the company will expand geographically, make alliances with more distribution partners and launch further unique tests. SenzaGen has its headquarters in Lund in Sweden and a subsidiary in San Francisco, USA. For more information visit http://www.senzagen.com

About Eurosafe
Eurosafe is a French based CRO. Over 30 years Eurosafe has served its customers all around the world for developing cosmetics and pharmaceuticals with 3 kinds of services : in vitro assays, tests on volunteers and regulatory toxicology. Our offering completed now with the GARDskin™ and GARDpotency™ together with our DPRA, H-Clat and Sens-Is assays makes Eurosafe unique in the EU with a complete set of standard and innovative sensitization assays.

This information was submitted for publication, through the contact person set out above on July 16th 2018 at 08:50

SenzaGen AB is listed on Nasdaq First North in Stockholm and FNCA is the company’s Certified Adviser. For more information, please visit http://www.senzagen.com

The recently granted Chinese patent covers the analytical methods and genetic signatures that form the basis of SenzaGen’s GARDskin™ technology. The patent is valid until October 2031.

“China is a potentially important future market for us, and patent protection in China is another confirmation of our technology’s merits and a new milestone in establishing our unique GARDskin™ test method as a global industry standard. This complements European patent protection and further strengthens our potential in the global market of in vitro tests,” says SenzaGen CEO, Anki Malmborg Hager.

A vital part of SenzaGen’s business development is relations with contract laboratories, industry, government agencies and NGOs concerned with alternative testing methods. The market for in vitro methods is growing rapidly, although experiments on animals are still permitted for allergy tests in some parts of the world. Asia is a huge market and is growing fast, and it is therefore essential for SenzaGen to prepare the way for a future introduction of its tests there.

The announcement from the Chinese Patent Office relates to Chinese Patent No. CN 103429756 B entitled: “Analytical methods and arrays for use in the identification of agents inducing sensitization in human skin”. Corresponding patent applications are currently being processed by the patent authorities in Brazil, Canada, Hong Kong, India, South Korea and the United States.

About GARD™
GARD™ is a group of tests for assessing chemical skin sensitizers. The tests make use of genetic biomarkers for more than 200 genes which cover the entire immune reaction and are relevant to predicting the risk of hypersensitivity. The tests have over 90 percent reliability. This compares with the current predominant test method, experiments on mice, which has an accuracy of 70-75 percent. SenzaGen’s tests are also capable of measuring the potency of a substance’s allergenic properties. Consequently, GARD tests provide a much more comprehensive basis for determining whether a substance should be classified as an allergen than current testing methods.

About SenzaGen
SenzaGen makes it possible to replace animal experiments with in vitro genetic testing to determine the allergenicity of the chemicals we come into contact with in our daily lives, such as for example in cosmetics, pharmaceuticals, food products and dyes. The company’s patented tests are the most reliable on the market and provide more information than traditional evaluation methods. We ourselves sell the tests in Sweden and the USA, and we sell through partners in several other countries. Over the next few years the company will expand geographically, make alliances with more distribution partners and launch further unique tests. SenzaGen has its headquarters in Lund in Sweden and a subsidiary in San Francisco, USA. For more information visit http://www.senzagen.com.

The information was submitted for publication, through the contact person set out above on July 11th 2018 at 08:50

SenzaGen AB is listed on Nasdaq First North in Stockholm and FNCA is the company’s Certified Adviser. For more information, please visit http://www.senzagen.com.

GARDpotency™ is based on the same biological platform as GARDskin™ and both tests are expected to be approved and recommended at the same time. Together with GARDpotency™, which complements GARDskin™, SenzaGen’s allergy test will be unique on the market, as it is the only test that offers animal-free tests of chemicals in line with the EU’s CLP classification. The CLP classification follows the Global Harmonized System, GHS, developed by the UN to create common criteria for the classification and labelling of chemicals.

The EU Chemicals Agency ECHA, which regulates chemical use based on the REACH Regulation, requires that chemicals that may induce sensitivity (sensitization) must be potency-classified according to CLP. This has so far only been possible with a so-called LLNA (Local Lymph Node Assay) evaluation, which is an in vivo test using animals. SenzaGen’s GARD™ test platform is based on human cells in vitro and genomic biomarkers, constantly delivering better accuracy than animal tests.

“Potency is extremely difficult to measure. We are therefore very happy to be able to report these results. In view of the impressive validation results for GARDpotency™, we look forward to receiving the authorities’ response regarding GARDskin™ and GARDpotency™ in 2019. As a consequence of these good results, we are planning to communicate sales targets for the coming years during the second half of this year. A positive response would make our allergy test the first animal-free test that can be used for classification in accordance with CLP, the EU’s standard,” says Anki Malmborg Hager, CEO of Senzagen.

The results from the validation report will be presented at forthcoming scientific conferences.

About GARD™GARD™ is a group of tests for assessing chemical skin sensitizers. The tests make use of genetic biomarkers for more than 200 genes which cover the entire immune reaction and are relevant to predicting the risk of hypersensitivity. The tests have over 90 percent reliability. This compares with the current predominant test method, experiments on mice, which has an accuracy of 70-75 percent. SenzaGen’s tests are also capable of measuring the potency of a substance’s allergenic properties. Consequently, GARD tests provide a much more comprehensive basis for determining whether a substance should be classified as an allergen than current testing methods.

About SenzaGenSenzaGen makes it possible to replace animal experiments with in vitro genetic testing to determine the allergenicity of the chemicals we come into contact with in our daily lives, such as for example in cosmetics, pharmaceuticals, food products and dyes. The company’s patented tests are the most reliable on the market and provide more information than traditional evaluation methods. We ourselves sell the tests in Sweden and the USA, and we sell through partners in several other countries. Over the next few years the company will expand geographically, make alliances with more distribution partners and launch further unique tests. SenzaGen has its headquarters in Lund in Sweden and a subsidiary in San Francisco, USA. For more information visit http://www.senzagen.com.

The information was submitted for publication, through the contact person set out above on the 6 July 2018 at 08:50

SenzaGen AB is listed on Nasdaq First North in Stockholm and FNCA is the company’s Certified Adviser. For more information, please visit http://www.senzagen.com.

https://senzagen.com/wp-content/uploads/2017/09/SenzaGen-Logotype-Square-Color-RGB_300px_wide.jpg300300admin_senzagenhttps://senzagen.com/wp-content/uploads/2017/01/LoggaSquare_RGB_liten_HF.pngadmin_senzagen2018-07-09 06:50:002018-07-16 07:43:56SenzaGen's final validation report for the animal-free allergy test GARDpotency™ has been submitted to the regulatory authorities